Job Description
General
Maintain knowledge in the current and relevant regulations and guidance in accordance with role demands and changes
Provide guidance and advice on regulatory requirements.
Support the execution of Quality Management System
Perform QA Review of Controlled Documents within the eQMS
Ensure accurate completion of timesheets on a weekly basis
Assist in the implementation of a positive quality culture within the quality team & operations
Specific
Execute audits (including study & process audits/self-inspections) against agreed programme(s) and schedules.
Support Quality Incident investigations, OOS, Change Control and CAPA to completion
Liaise with clients and internal stakeholders in the preparation and execution of quality agreements.
Review/Audit CSV documentation.
Monitor the Quality Events mailbox
Review AS Methods, Deviations, SOPs
Occasional travel to Resolian Sandwich may be required
CAPA Assessment
Vendor Assessments and audits...
Maintain knowledge in the current and relevant regulations and guidance in accordance with role demands and changes
Provide guidance and advice on regulatory requirements.
Support the execution of Quality Management System
Perform QA Review of Controlled Documents within the eQMS
Ensure accurate completion of timesheets on a weekly basis
Assist in the implementation of a positive quality culture within the quality team & operations
Specific
Execute audits (including study & process audits/self-inspections) against agreed programme(s) and schedules.
Support Quality Incident investigations, OOS, Change Control and CAPA to completion
Liaise with clients and internal stakeholders in the preparation and execution of quality agreements.
Review/Audit CSV documentation.
Monitor the Quality Events mailbox
Review AS Methods, Deviations, SOPs
Occasional travel to Resolian Sandwich may be required
CAPA Assessment
Vendor Assessments and audits...
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